Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer

NCT05223647 | Terminated Phase 3 DMC

• 2 other identifiers: EC#2307662020203
• Study Type: interventional
• Target: 239
• Locations: 5 countries
• Sites: 20

Brief Summary

Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. The main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in ES SCLC patients receiving carboplatin/etoposide/durvalumab.

Conditions

Small-cell Lung Cancer

Keywords

cancer; chemotherapy; radiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Change in 1-year overall survival

  The Cox proportional hazards method will be used to compare survival between the treatment groups.

  14 months after last patient entry

Secondary Outcomes (7)

• Change in 2-, 3-, 4- and 5-year survival rate

  2, 3, 4 and 5 years after last patient entry

• Frequency and severity of adverse events

  Through study completion, an average of 1 year after last patient entry

• Change in progression free survival (PFS)

  Through study completion, an average of 1 year after last patient entry

• Change in overall response rates

  Through study completion, an average of 1 year after last patient entry

• Change in response rates in non-irradiated lesions

  Through study completion, an average of 1 year after last patient entry

Other Outcomes (3)

• Change in cognitive function from baseline to end of treatment

  Through study completion, an average of 2 years after last patient entry

• Frequency and timing of brain metastases

  Through study completion, an average of 2 years after last patient entry

• Associations between outcomes of study treatment and biomarkers in tissue, blood and stool

  Through study completion, an average of 2 years after last patient entry

Study Arms (2)

Chemo-immunotherapy plus thoracic radiotherapy

EXPERIMENTAL

Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. Thoracic radiotherapy of 30 Gy/10 fractions between 2nd and 3rd carboplatin/etoposide/durvalumab course.

Procedure: Thoracic radiotherapy; Drug: Chemo-immunotherapy

Chemo-immunotherapy

ACTIVE COMPARATOR

Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.

Drug: Chemo-immunotherapy

Interventions

Thoracic radiotherapy PROCEDURE

30Gy/10 fractions thoracic radiotherapy given between 2nd and 3rd course of chemo-immunotherapy.

Chemo-immunotherapy plus thoracic radiotherapy

Chemo-immunotherapy DRUG

Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.

Also known as: carboplatin/etoposide/durvalumab

Chemo-immunotherapy; Chemo-immunotherapy plus thoracic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years at time of study entry
• ECOG performance status of 0 or 1
• Body weight \>30 kg
• Adequate bone marrow, liver and kidney function
• Life expectancy of at least 3 months
• At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 30 Gy/10 fractions
• Histologically or cytologically confirmed SCLC
• Stage III-IV disease (TNM v8)
• FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
• Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment

You may not qualify if:

• Previous chemo-, immuno- or radiotherapy for SCLC
• Major surgical procedure last 28 days
• History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
• Uncontrolled intercurrent illness
• Other active malignancy
• Leptomeningeal carcinomatosis
• Immunosuppressive medication
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital of North Norway: collaborator
• Erasmus Medical Center: collaborator
• Sahlgrenska University Hospital: collaborator
• Karolinska University Hospital: collaborator
• North Estonia Medical Centre: collaborator
• Alesund Hospital: collaborator
• Helse Stavanger HF: collaborator
• Oslo University Hospital: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Helse Fonna: collaborator
• Drammen sykehus: collaborator
• University Hospital, Akershus: collaborator
• Gävle Hospital: collaborator
• Sykehuset Innlandet HF: collaborator
• Nordlandssykehuset HF: collaborator
• Landspitali University Hospital: collaborator
• Lund University Hospital: collaborator
• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Haukeland University Hospital: collaborator
• University Hospital, Linkoeping: collaborator

Study Sites (20)

North Estonia Medical Centre

Tallinn, Estonia

Location

Landspitali University Hospital

Reykjavik, Iceland

Location

Erasmus MC

Rotterdam, Netherlands

Location

Ålesund Hospital

Ålesund, Norway

Location

Haukeland Universitetssykehus

Bergen, Norway

Location

Nordlandssykehuset HF

Bodø, Norway

Location

Drammen sykehus - Vestre Viken

Drammen, Norway

Location

Innlandet hospital Gjøvik

Gjøvik, Norway

Location

Haugesund hospital

Haugesund, Norway

Location

Sykehuset Levanger

Levanger, Norway

Location

Akershus Universitetssykehus AHUS

Oslo, Norway

Location

Oslo University Hospital Ullevål

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

University Hospital of North Norway, Pulmonology Department

Tromsø, Norway

Location

Cancer Clinic at St. Olavs Hospital

Trondheim, Norway

Location

Gävle hospital

Gävle, Sweden

Location

Sahlgrenska Sjukehuset

Gothenburg, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Lund University Hospital

Skåne, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Magnus Steigedal, PhD

  Department of Clinical and Molecular Medicine, NTNU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 4, 2022
• Study Start: January 11, 2022
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: December 2029
• Access Criteria: The repository is based on Dataverse, and available for anyone.

Locations

SE (5); IC (1); NL (1); ES (1); NO (12)